SPIRIVA RESPIMAT eases the effort to inhale the medicine

The slow-moving mist delivers the same SPIRIVA medicine as HandiHaler, but independent of inspiratory effort.1,2

  • SPIRIVA RESPIMAT COPD Inhaler Delivery, IconActive Delivery
    There’s no need to sharply inhale to release the medicine2,3
  • SPIRIVA RESPIMAT COPD Inspiratory Effort, IconIndependent of Inspiratory Effort
    Delivers nebulized medicine for inspiratory ease1,3
  • Lung Deposition, IconDeep Lung Deposition
    Small particle-sized droplets deposit deep into peripheral airways1,3*†

*As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).1

There is no correlation between deposition data and clinical efficacy. Active ingredients used in the studies are not commercially available in RESPIMAT. The specific physical-chemical characteristics of the drug may affect the lung deposition.

SPIRIVA RESPIMAT Inhaler for COPD Maintenance Treatment

GOLD 2019 SUGGESTS THAT INHALER CHOICE MATTERS REGARDLESS OF DISEASE SEVERITY, PATIENTS MAY NOT BE ABLE TO GENERATE THE OPTIMAL PEAK INSPIRATORY FLOW REQUIRED BY MANY DPIs—INCLUDING HANDIHALER®—TO OPTIMALLY ACTIVATE THEM.

If your patients aren't responding to treatment, make an assessment11

When assessing a patient’s experience:

  • Consider escalating or de-escalating treatment
  • Assess inhaler technique and adherence, and consider switching inhaler device or molecules within the same class (eg, using a different long-acting bronchodilator)
  • Subsequently review clinical response, including side effects

How do you improve your patients’ inhalation experience? Switch them from SPIRIVA HandiHaler to SPIRIVA RESPIMAT

SPIRIVA RESPIMAT Inhaler Comparison Chart

Switch to the inhaler designed to be easy on damaged lungs: SPIRIVA RESPIMAT

SPIRIVA RESPIMAT Inhaler Device Video

See the RESPIMAT Inhaler in action

You and your patients can watch this video to learn more about the RESPIMAT mist.

Watch Video

Help your patients prepare and use SPIRIVA RESPIMAT

Preparing the Inhaler
for First-Time Use1
  1. Remove clear base
    • Keep the cap closed
    • Press the safety catch while firmly pulling off the clear base with your other hand. Be careful not to touch the piercing element
    • Write the discard by date on the label (3 months from the date the cartridge is inserted)
  2. Insert cartridge
    • Insert the narrow end of the cartridge into the inhaler
    • Place the inhaler on a firm surface and push down firmly until it clicks into place
  3. Replace clear base
    • Put the clear base back into place until it clicks
    • Do not remove the clear base or the cartridge after it has been put together
  4. Turn
    • Keep the cap closed
    • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn)
  5. Open
    • Open the cap until it snaps fully open
  6. Press
    • Point the inhaler toward the ground
    • Press the dose-release button
    • Close the cap
    • If you do not see a mist, repeat steps 4 to 6 until a mist is seen.
    • After a mist is seen, repeat steps 4–6 three more times
    • After complete preparation of your inhaler, it will be ready to deliver the number of puffs on the label

3 steps for daily use

After preparing the inhaler, patients can remember the steps for daily use with TOP1. Take 2 puffs, 1 time daily, to receive the full dose of medication.1

SPIRIVA RESPIMAT Inhaler Dosing Instructions, Turn

Turn1

  • Keep the cap closed
  • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn)
SPIRIVA RESPIMAT Inhaler Dosing Instructions, Open

Open1

  • Open the cap until it snaps fully open
SPIRIVA RESPIMAT Inhaler Dosing Instructions, Press

Press1

  • Breathe out slowly and fully
  • Close your lips around the mouthpiece without covering the air vents
  • Point the inhaler to the back of your throat
  • While taking a slow, deep breath through your mouth, Press the dose-release button and continue to breathe in
  • Hold your breath for 10 seconds or for as long as comfortable
  • Repeat Turn, Open, Press (TOP) for a total of 2 puffs
  • Close the cap until you use your inhaler again

DOWNLOAD THE QUICKSTART GUIDE

an easy, step-by-step guide on how to assemble and prepare the RESPIMAT inhaler

Download

See the RESPIMAT inhaler in action

SPIRIVA RESPIMAT COPD Inhaler

With SPIRIVA RESPIMAT, remember to tell your patients

1 DOSE = 2 PUFFS, 1 TIME DAILY1

For detailed instructions, patients should refer to the Instructions for Use enclosed with their prescription.

Note: SPIRIVA RESPIMAT should not be sprayed in the eyes as this may cause blurred vision and pupil dilation.1

SPIRIVA RESPIMAT Dose Indicator

Dose Indicator

The dose indicator shows approximately how many puffs are left in the inhaler. When the dose indicator enters the red area of the scale you need to refill your prescription as soon as possible. When the dose indicator reaches the end of the red scale, your SPIRIVA RESPIMAT is empty and automatically locks. At this point, the clear base cannot be turned any further.

Back to top

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

SEE MORE

INDICATIONS FOR SPIRIVA RESPIMAT AND SPIRIVA HANDIHALER

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

SPIRIVA RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

Important Safety Information for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium, or any component of either product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA is intended as a once-daily maintenance treatment and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2‑agonist should be used.

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2‑adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

More Important Safety Information

Important Safety Information for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (continued)

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA.

SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short‑acting beta2‑agonist, such as albuterol. Treatment with SPIRIVA should be stopped and other treatments considered.

SPIRIVA should be used with caution in patients with narrow‑angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow‑angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder‑neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non‑specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4‑year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic‑containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device. The HANDIHALER device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

Please see full Prescribing Information for SPIRIVA RESPIMAT including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and Instructions for Use.

INDICATIONS FOR SPIRIVA RESPIMAT AND SPIRIVA HANDIHALER

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

SPIRIVA RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

Please see full Prescribing Information for SPIRIVA RESPIMAT including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and Instructions for Use.

CL-SVR-0045 02.15.2017

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT (continued)

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma‑related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life‑threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2‑agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow‑angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow‑angle glaucoma develop.

Use with caution in patients with urinary retention especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS

  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta‑agonists.
  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta‑agonists, but may produce severe bronchospasm in patients with COPD.
  • Avoid co‑administration of STIOLTO with other anticholinergic‑containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Inform patients not to spray STIOLTO into the eyes as this may cause blurring of vision and pupil dilation.

Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

CL-STO-100021 6.5.2019

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2‑adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

SEE MORE

INDICATIONS FOR SPIRIVA RESPIMAT AND SPIRIVA HANDIHALER

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

SPIRIVA RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

Important Safety Information for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium, or any component of either product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA is intended as a once-daily maintenance treatment and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2‑agonist should be used.

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2‑adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

More Important Safety Information

Important Safety Information for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (continued)

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA.

SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short‑acting beta2‑agonist, such as albuterol. Treatment with SPIRIVA should be stopped and other treatments considered.

SPIRIVA should be used with caution in patients with narrow‑angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow‑angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder‑neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non‑specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4‑year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic‑containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device. The HANDIHALER device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

Please see full Prescribing Information for SPIRIVA RESPIMAT including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and Instructions for Use.

INDICATIONS FOR SPIRIVA RESPIMAT AND SPIRIVA HANDIHALER

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

SPIRIVA RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

Please see full Prescribing Information for SPIRIVA RESPIMAT including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and Instructions for Use.

CL-SVR-0045 02.15.2017

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT (continued)

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma‑related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life‑threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2‑agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow‑angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow‑angle glaucoma develop.

Use with caution in patients with urinary retention especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS

  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta‑agonists.
  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta‑agonists, but may produce severe bronchospasm in patients with COPD.
  • Avoid co‑administration of STIOLTO with other anticholinergic‑containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Inform patients not to spray STIOLTO into the eyes as this may cause blurring of vision and pupil dilation.

Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

CL-STO-100021 6.5.2019

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2‑adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

References

  1. SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2019.
  2. Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med. 2005;18(3):264–272.
  3. Wachtel H, Kattenbeck S, Dunne S, Disse B. The Respimat® development story: patient-centered innovation. Pulm Ther. 2017;3(1):19-30.
  4. Jarvis S, Ind P, Shiner R. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007;36(2):213-218.
  5. SPIRIVA HANDIHALER [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2019.
  6. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
  7. Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: comparison of RESPIMAT with conventional metered-dose inhalers with and without spacer devices. Chest. 1998;113(4):957-963.
  8. Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat® Soft Mist Inhaler than HFA-MDI in COPD patients with poor technique. 2008;3(4):763-770.
  9. Hochrainer D, Hölz H, Kreher C, Scaffildi L, Spallek M, Wachtel H. Comparison of the aerosol velocity and spray duration of Respimat® Soft Mist Inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005;18(3):273-282.
  10. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® Soft Mist Inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl). 2011;4:145-155. doi:10.2147/MDER.S7409.
  11. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2019 Report. https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf. Updated November 2018. Accessed March 5, 2019.